R2 plans introduction of LungCheck

By Robert Bruce

Even as R2 Technology's ImageChecker CAD mammography system seems to be catching on with radiologists and patients, the company is starting clinical trials on a CT lung cancer detection system it believes will be even more successful.

GE Medical Systems has an agreement with R2 to install ImageChecker software on GE's Senographe 2000D, the full-field digital mammography system that is FDA-approved. GE just received approval for soft-copy reads last week, which should give R2 Technology a big boost.

Privately owned R2 will introduce a prototype lung-screening CAD system at the RSNA show this month that it claims will raise the software competency of low-dose CT scanners to that of the hardware, according to Susan Wood, Ph.D., director of CT products for the firm.

"The scanner manufacturers' hardware produces images of much greater diagnostic value than previous scanners, but the ability of the radiologist to interpret that data has diminished because of the increased number of slices acquired," Wood said. "Our image interpretation tools will assist the radiologist in making his or her diagnosis more efficiently."

The ink is barely dry on the Kodak-R2 deal, so the two companies have yet to put together a product plan.

According to the World Health Organization, there are one billion smokers worldwide. If lung cancer screening were to become as widespread as mammography, CAD firms such as R2 and its nearest competitor, CADx, would benefit enormously‹provided the reimbursement money were available to support it.

And CAD screening doesn't stop there, R2's CEO Mike Klein sees the company moving into other modalities such as MRI and taking the detection software into cardiology or neurology.

"We see the algorithm set to be robust enough to capture biological anomalies, examining function, and then combining through image fusion with x-ray or CT images that show spatial relationships," Klein said.

Although pulmonary products will be the focus at the RSNA meeting, the long-term vision is whole-body scanning with CT, Wood said.

Of course, other technologies are after the same market. Some clinics already offer full-body electron-beam CT. These scans are not covered by insurance and they may be both good and bad for patients. Radiologists say that EBCT could find previously undetected disease, but because a large percentage of the population harbors benign abnorIn fact, the company believes it has a product that could be classified as "diagnostic" for lung cancer and pulmonary embolism, rather than the "detection" classification attached to ImageChecker.

The problem with chest x-ray screening for lung cancer is that there is no statistical decrease in mortality, as lesions visible on chest films have likely already metastasized. R2 is banking on the anatomical clarity CT provides, along with the company's new CAD system, to make mass lung cancer screening even more popular than mammography.

"We're approaching potential strategic partners such as GE and Siemens, which are interested because a lung cancer study last year showed 88 million current or former smokers in the U.S. population," said Klein.

Lung cancer is the number one cause of death among all cancers. There's no screening program as there is for breast, prostate, and colorectal cancers. The reason is that chest x-ray sensitivity is such that by the time the cancer is picked up, the morbidity is 0.85. The five-year survival rate for lung cancer is 15%.

R2 will call the CT CAD product the "LungCheck." The Windows NT-based application has been developed as a stand-alone product prototype that the company would sell as a workstation or a software component product that can be integrated into a standard CT workstation, Klein said. R2's working relationship with the FDA is good enough to get a quick premarket approval (PMA) for the ImageChecker, he added.

R2 will also introduce the next generation of ImageChecker software, which Klein said will greatly improve the likelihood of breast cancer detection.

"The 3.0 software will have a feature set that shows a Œprominent mass marker' with a circle around it. This has approximately a four to five times greater probability of being a cancerous lesion than a normal mark," he said. "The marker is much more specific in finding cancer, with the false positives being much less."

R2 has signed several strategic partnerships, notably with Eastman Kodak. Kodak and R2 will jointly develop CAD applications, said Jane Hasselkus, Kodak's worldwide category manager for DR.

"We will identify regions of interest. It could evolve into a lung cancer screening application," Hasselkus said. "This will help optimize the value of those digitized images." The R2 CAD software could be used with Kodak's CR and DR platforms, Hasselkus said. Kodak has no plans to develop CT, she added. "Some research we're doing with CR shows it can be as effective a tool as CT when combined with CAD," she said.